Pharmaceutical Manufacturing

FRIABILITY

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A tablet’s strength has a significant impact on its marketing, transportation and dissolution. The mechanical strength of tablet or granules can be determined by its hardness and through friability test. A clear synthetic polymer drum with polished internal surfaces that is not susceptible to static buildup shouldbe used; it should have an internal diameter of 283 to 291 mm and a depth of 36 to 40 mm. The drum has a detachable side. A curving projection that runs from the center of the drum to the outside wall and has an inside radius of 75.5 to 85.5 mm tumbles the tablets with each rotation of the drum. A device that revolves at 25 ±1 rpm has the drum fixed to its horizontal axis. As a result, the tablets slide or roll during every rotation, landing on the drum wall or one another. Friability test procedure and Acceptance Criteria

Various techniques for formulating coating solutions

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Formulation of the coating solution: Adequate preparation of the coating solution is essential for achieving an effective coating within a reasonable timeframe. This solution is prepared in S S vessels equipped with a stirrer. Various techniques are beneficial in facilitating the prompt formulation of coating solutions: Dispersion in hot water: The coating materials remain insoluble … Read more

Types of Water used in Pharmaceutical Industry

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Water is commodiously used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents. Types of Water: Raw Water: Raw water is a natural water available in the environment, such as rainwater, ground water, and water from bodies like lakes … Read more

UNDERSTANDING PRE-REQUISITES FOR TECHNOLOGY TRANSFER

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Technology transfer is both integral and critical to drug discovery and development process for new medicinal drug products. A major decision focuses on that point where the idea or process is advanced from a research-oriented program to targeted toward commercialization. Generally, the cost of product development rises dramatically during the pilot scale-up and initial production … Read more

HANDLING OF ALTERNATE VENDOR DEVELOPMENT (AVD) PROJECTS:

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Alternate Vendor development for existing material shall be initiated through the Change control procedure. Supply chain / purchase team on its own or on the recommendation of Technology Transfer team / R&D / Production shall identify the vendor for existing material. Supply Chaim (SCM) / purchase Team shall initiate queries with the prospective vendors for … Read more

UNDERSTANDING ON WORKING PRINCIPLE OF BLENDER

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Blending in its simplest form is the combining of two or more materials to produce a homogeneous mixture. These materials may be any combination of particulate (solids blending) or particulate and liquid (liquid-solid blending). Normal tumble blending of free-flowing materials provides a gentle mixing action. For materials that tend to lump or for high intensity … Read more

UNDERSTANDING ON WORKING PRINCIPLE OF RAPID MIXER GRANULATOR (RMG):

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Homogenous mixing of dry & wet powders, de-agglomeration / de-lumping of wet mass and fast dispersion of binding agent. Dust free, high free flowing dosing particles, high uniformity of granule size. AC frequency control for bottom driven Impeller Mixer with 3 or 4 blades with exclusive scrape side design and Chopper positioned to make granules. … Read more

UNDERSTANDING ON WORKING PRINCIPLE OF FLUID BED DRYER (FBD):

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Fluid Bed Dryers (FBD) are primarily used in almost all chemical, pharmaceutical, food, dyestuff and other process industries to dry materials by fluidization with hot and / or dehumidified air, which creates a turbulence in the wet product (not totally liquid) while flowing through it. WORKING PRINCIPLE: The atmospheric air is sucked in the dryer … Read more

UNDERSTANDING ON WORKING PRINCIPLES OF SIFTER (VIBRATORY SIFTER):

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VIBRO SIFTER, VIBRO SCREEN: Vibro separators are circular gyratory screens used to separate solids from solids and liquid from solid. Vibro Sifter consists of Specially Designed Motor mounted vertically at the center of the base plate of the Screen. The Screen is in between feeding hopper and bowl. The material is fed on to the … Read more

BASIC UNDERSTANDING OF DIFFERENT EQUIPMENT AND CRTICAL OPERATING PARAMETRS:

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Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the … Read more